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Search Results Within Category "Blood Disorders"

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9 Study Matches

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.

For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.

Yes
 

Robert Greiner
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT01656603
STUDY00015052
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Inclusion Criteria:
You have a disorder affecting your hematopoietic system (the organs and tissues that produce your blood) that is inherited, acquired, or from previous chemotherapy

Exclusion Criteria:
You are receiving licensed cord blood products
You are receiving unlicensed CB products from other CB banks
Blood Disorders, Cancer
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Hershey, PA ,

ATHN 10: Rare Coagulation Disorders Project

This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).

One tube of blood will be collected during a routine clinic visit.

Yes
 

M. Elaine Eyster
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
SITE00000669
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Inclusion Criteria:
Subject must have an established Rare Coagulation Disorder diagnosis (
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset

Exclusion Criteria:
Subject is unwilling to sign informed consent form
Blood Disorders
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Hershey, PA ,

A Phase 3, single-arm, open-label, multicenter study of thesafety and efficacy of dirloctocogene samoparvovec(SPK-8011, adeno-associated viral vector with B-domaindeleted human factor VIII gene) in adults with severe ormoderately severe hemophilia A (KEYSTONESM 1)

This is a Phase 3 study of single-dose SPK-8011 AAV gene therapy in combination with immunomodulation. Patients will receive a one-time dose of SPK 8011, three weeks of methylprednisolone & then will be followed for safety & efficacy per study schedule.

1) Screening period of < 8wks.-1 visit2) Lead-in for >24 wks.-1 visit3) Pre-dose day -24-1 visit4) Dosing-Day 1 & Day 2-2 visits5) Primary study (15 mos.)-37 visits6) Long term follow-up approx. 9 yrs.-20 visitsSome visits may be done via home health when a physical isn't required.

$75.00 travel reimbursement per visit

Yes
 

M. Elaine Eyster
Cynthia Campbell-Baird - at cbaird@psu.edu or 717-531-5777
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03003533
STUDY00022779
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Inclusion Criteria:
Adult males (>18yrs.) with severe or moderately severe hemophilia A
>150 documented exposure days to a FVIII protein product
No evidence of cirrhosis or advanced liver disease
Negative test for inhibitor against FVIII during screening
No documented FVIII inhibitor in 5 yrs. prior to screening

Exclusion Criteria:
Positive anti-AAV Spark200NAb result
Currently undergoing antiviral therapy
Have an inherited bleeding or acquired disorder other than hemophilia A
Prior treatment with a vector or gene transfer agent
Major surgical procedure planned in a 15 month period following SPK 8011 infusion
Blood Disorders
Not applicable
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Hershey, PA ,

Study of Angelica gigas dietary supplements (Cogni.Q) and potential effects on human immune cells

This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. We had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.Approximately 40 men will take part in this research study at Hershey Medical Center.

Yes
 

Junxuan Lu
Deepkamal Karelia - at dkarelia@pennstatehealth.psu.edu or 717-531-0003, ext=285476
Pharmacology (HERSHEY)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00008009
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Inclusion Criteria:
Male subjects 21 to 65 years of age
Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19=< BMI >=30
Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR).
Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)

Exclusion Criteria:
Subjects positive for HIV, HBV and HCV (self-reported)
Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded.
Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study.
Non-English-speaking subjects
Infectious Diseases & Immune System, Blood Disorders, Food & Nutrition
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Hershey, PA ,

Understanding the Relationship Between Discrimination and Sickle Cell Pain

This is a survey and interview study recruiting patients with sickle cell disease (SCD). Participants will answer questionnaires and complete a remote interview about health care experiences, pain, and discrimination. Natural language processing of interview transcripts will be used to quantify linguistic features indicative of subjective associations between individual experiences of racial discrimination and sickle cell pain.

Participants will be asked to fill out questionnaires and answer questions during an interview.

$50

No
 

Elizabeth Losin
Jacob Gronemeyer - at jgronemeyer@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00023905
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Inclusion Criteria:
A diagnosis of Sickle Cell Disease
18 years or older

Exclusion Criteria:
Under the age of 18
Does not have a confirmed diagnosis of Sickle Cell Disease
Unable or unwilling to participate in the interview or to be recorded
Not Fluent in the English langauge
Blood Disorders, Pain Management
Not applicable
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A Global, Open-Label, Adaptive Design Study to Investigate the Efficacy and Safety of SerpinPC With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

This is an open-label drug study of SerpinPC (a subcutaneously administered drug) for patients with severe hemophilia A or moderately severe to severe Hemophilia B. The study consists of 3 parts after an observation phase of 12-24 weeks: 24 week justification phase, 24 week confirmatory phase &amp; 24 week extension phase.

This is a subcutaneous drug treatment clinical trial with an observation period of up to 24 weeks, pre-dosing/dosing period of 8 visits on site or phone calls &amp; an extension period of 6 visits.

$75.00 travel reimbursement per visit

Yes
 

M. Elaine Eyster
Cynthia Campbell-Baird - at cbaird@pennstatehealth.psu.edu or 717-531-5777
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
All
This study is NOT accepting healthy volunteers
NCT05789524
STUDY00022327
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Inclusion Criteria:
Males ages >12 & <65 with severe hemophilia A or moderately severe to severe hemophilia B
Subjects include prophylactic dosing or on-demand dosing for factor replacement
Adequate laboratory functions

Exclusion Criteria:
Subjects with a previous factorVIII or factor IX inhibitor
Previous deep vein thrombosis, pulmonary embolism, MI or stroke.
Uncontrolled hypertension, active cancer (except basal cell)
Weight > 150kg (330 lbs.) or BMI > 40kg/m2
Blood Disorders
Not applicable
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Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis

A research study looking at how safe it is to switch from emicizumab (Hemlibra) to Mim8 in people with haemophilia A.

The study will last for about 6-12 months. Subjects will have between 6 and 27 Mim8 injections depending on dosing frequency. There will be 9 clinic visits. Blood will be drawn at all 9 of the visits.

$75 per visit to cover travel expenses

Yes
 

M. Elaine Eyster
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT05878938
STUDY00022172
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Inclusion Criteria:
Congenital haemophilia A of any severity based on medical records
Treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
Age 12 years or above at the time of signing the informed consent.
Patients for whom the decision to discontinue emicizumab treatment has been made.
Willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires.

Exclusion Criteria:
Participation in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks before screening
Previous or current thromboembolic disease or events or risk of thromboembolic disease, as evaluated by investigator or risk of thromboembolic disease, as evaluated by investigator.
Receipt of FVIII gene therapy at any time.
Ongoing or planned immune tolerance induction therapy.
Minor or major surgery planned to take place after screening and during the 26-week treatment period.
Blood Disorders
Not applicable
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Hershey, PA ,

External performance evaluation of INNOVANCE D-Dimer 2.0 on CS-5100

This is a multi-site prospective laboratory analysis of blood specimens utilizing the investigational Innovance 2.0 D-Dimer assay compared to the FDA-approved Innovance 1.0 D-Dimer assay on the FDA-approved CS-5100 instrument. Subjects will be required to provide up to 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting.

If you choose to participate in the study, you will have no more than 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers 10 years and older with confirmed clots in the legs or lungs, or diseases and conditions with increased coagulation activation such as thromboembolic disease, acute aortic dissection, myocardial infarction, malignant diseases, obstetrical complications, third trimester of pregnancy, surgery or polytrauma, sepsis or severe infection. We are looking for healthy volunteers 18 years and older as well.

$75

Yes
 

Olajumoke Oladipo
EMILY MACMILLEN - at emacmillen1@pennstatehealth.psu.edu or 717-531-0003, ext=287538
Pathology: Clinical (HERSHEY)
 

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All
This study is also accepting healthy volunteers
STUDY00024678
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Inclusion Criteria:
10 years of age or older
Patient with known clot or condition above
Healthy adult (>18) volunteer
Willing to donate a small amount of blood

Exclusion Criteria:
<10 years of age
If healthy volunteer, currently pregnant or hospitalization within the past month
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day
Strenuous exercise in the 60 minutes prior to blood draw
Blood Disorders, Heart & Vascular, Pregnancy & Infertility
Experimental device compared to an approved device
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External design verification study on CN-6000 system.

The purpose of this prospective, multi-site study is to conduct a clinical evaluation of the investigational CN-6000 device using venous plasma specimens from adult participants in different care settings with various disease processes. This is a fully automated blood coagulation analyzer intended for in-vitro diagnostic use to analyze clotting, chromogenic and immuno-chemical methods in 3.2% Na citrated plasma in a clinical laboratory. No more than 2 venous blood draws will be attempted to obtain up to 4 whole blood specimens per subject, totaling no more than 30 mL. Samples may also be tested on the CS-5100 predicate comparator device.

This study will require 1 visit to Hershey Medical Center on a single day for up to two blood draws, no more than 2 tablespoons of blood (30 ml) total. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers with coagulation disorders and healthy volunteers.

$75

Yes
 

Olajumoke Oladipo
Emily MacMillen - at DEMResearch@pennstatehealth.psu.edu or 717-531-0003, ext=287538
Pathology: Clinical (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024281
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Inclusion Criteria:
18 or older
Patient with known or tested for clotting disorders
Patients with severe liver disease
Healthy people without clotting disease or recent hospital stay
Willing to undergo blood draw

Exclusion Criteria:
Known pregnancy or infection
Less than 18 years of age
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day
Blood Disorders, Digestive Systems & Liver Disease
Experimental device compared to an approved device
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Hershey, PA ,